Cleanability is also essential for all process components, which should be non-additive and non-absorptive, so the ultra-low surface energy and high material density of the GYLON Style 3522 significantly reduces the potential for bioburden at the inner surface of the gasket. The colorless and translucent nature of the material also aids visual inspection and cleaning validation.

Gasket performance directly impacts a manufacturer’s ability to safely and effectively operate a sanitary environment in pharmaceutical and bioprocessing industries,” says Stephen Doherty, Garlock’s global segment leader. “Regardless of whether the application is an integral part of the process, or within critical utilities such as clean steam, ultra-pure water (UPW) and water for injection (WFI), the demands on gasket material are tougher each year.”

In multiproduct facilities, gaskets must hold up to frequent clean-in-place (CIP) and sterilization-in-place (SIP) cycles involving harsh chemicals and high temperatures. Smaller batches, regular changeovers and a drive to minimize process downtime mean that gaskets are subjected to more frequent cleaning, a wider spectrum of process chemicals, extreme thermal cycling and fluctuating pressures during their expected performance life.

Most sanitary gaskets will also intrude or recede within hygienic couplings, leading to material build up and potential cross-contamination.

Frequent batch changes and cleaning cycles are placing more stress – mechanical and chemical – on gaskets and other soft parts used throughout the process,” Doherty says. “A gasket may physically degrade, introducing fragments of material into the process and creating a contamination event.